NCT03078374

Brief Summary

The purpose of this study is to obtain single-center safety and feasibility data on patients managed with reduced anti-coagulation, and the incidence of thrombotic and bleeding adverse events associated with the HeartMate 3 LVAS therapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable heart-failure

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

5 years

First QC Date

March 2, 2017

Last Update Submit

August 1, 2020

Conditions

Heart FailureCardiovascular Diseases

Keywords

Reduced anti-coagulation, mechanical circulatory support.

Outcome Measures

Primary Outcomes (1)

  • Survival-free rate of thromboembolic and hemorrhagic events

    12 month survival-free rate of thromboembolic events (i.e. pump thrombosis, disabling stroke MRS\>3) and hemorrhagic events (major bleeding, hemorrhagic stroke).

    12 months

Secondary Outcomes (1)

  • Adverse Events

    12 months

Study Arms (1)

Reduced Anticoagulation

OTHER

Reduced anticoagulation

Drug: Warfarin

Interventions

WarfarinDRUG

Reduced dosage to obtain lower INR range

Reduced Anticoagulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients implanted with HeartMate 3 LVAS irrespective of an indication
  • data collection for major thrombophilic mutations including anti-phospholipid syndrome and lupus anticoagulant testing prior to low-intensity protocol anticoagulation initiation has been performed
  • patient will be compliant with an anticoagulation management in a judgment of the investigator
  • patient in stable condition with anticipated home discharge

You may not qualify if:

  • absence of an informed consent
  • presence of additional MCS e.g. ECMO, RVAD in less than 7 days prior to low- intensity protocol anticoagulation initiation
  • known history of major thrombotic event e.g. DVT
  • presence of other than biological valve prosthesis in aortic position
  • hemodynamically significant or symptomatic carotid artery stenosis prior to low-intensity protocol anticoagulation initiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Netuka I, Sood P, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Marasco S, Beyersdorf F, Damme L, Schmitto JD. Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083.

    PMID: 26670056BACKGROUND

  • Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.

    PMID: 27959709BACKGROUND

  • Netuka I, Kvasnicka T, Kvasnicka J, Hrachovinova I, Ivak P, Marecek F, Bilkova J, Malikova I, Jancova M, Maly J, Sood P, Sundareswaran KS, Connors JM, Mehra MR. Evaluation of von Willebrand factor with a fully magnetically levitated centrifugal continuous-flow left ventricular assist device in advanced heart failure. J Heart Lung Transplant. 2016 Jul;35(7):860-7. doi: 10.1016/j.healun.2016.05.019. Epub 2016 May 31.

    PMID: 27435529BACKGROUND

  • Netuka I, Ivak P, Tucanova Z, Gregor S, Szarszoi O, Sood P, Crandall D, Rimsans J, Connors JM, Mehra MR. Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study. J Heart Lung Transplant. 2018 May;37(5):579-586. doi: 10.1016/j.healun.2018.03.002. Epub 2018 Apr 11.

    PMID: 29655662DERIVED

Related Links

MeSH Terms

Conditions

Heart FailureCardiovascular Diseases

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Heart Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ivan Netuka, MD, Ph.D.

    Institute for Clinical and Experimental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chairman of Cardiac Centre

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 13, 2017

Study Start

January 11, 2017

Primary Completion

January 1, 2022

Study Completion

October 1, 2022

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share